ISO INTERNATIONAL STANDARD 18242 First edition 2016-09-01 Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps Implants cardiovasculaires et systemes extracorporels - Pompes sanguines centrifuges Reference number A ISO 18242:2016(E) ISO International Organization for Standardization @IS02016 vided by IHS under IS0 18242:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISO copyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Intenationaibr PrganizationforStandardization etworking permitted without license from IHS IS0 18242:2016(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions 4 Requirements .3 4.1 Biological characteristics .3 4.1.1 Sterility and non-pyrogenicity .3 4.1.2 Biocompatibility. .3 4.2 Physical characteristics . .3 4.2.1 Blood pathway integrity 3 4.2.2 Prime volume. .3 4.2.3 Connector integrity. .3 4.3 Performance characteristics. .3 4.3.1 Hydraulic performance 3 4.3.2 Biood cell damage .3 4.3.3 Bearing durability ..4 4.3.4 Shelf life .4 5 Tests and measurements to determine compliance with this document. ..4 5.1 General 5.1.1 Tests and measurements .4 5.1.2 Operating variables . ..4 5.1.3 Temperature 4 5.1.4 Relationship between variables ..4 5.1.5 Procedures .5 5.1.6 Driver/console. .5. 5.2 Biological characteristics 5 5.2.1 Sterility and non-pyrogenicity "5 5.2.2 Biocompatibility 5 5.3 Physical characteristics 5 5.3.1 Blood pathway integrity .5 5.3.2 Primevolume 5 5.3.3 Connectors .5 5.4 Performance characteristics .6 5.4.1 Hydraulic performance .6 5.4.2 Biood cell damage. 6 5.4.3 Bearing wear .7 5.4.4 Shelflife .7 Information supplied by the manufacturer .1 6 6.1 Information on the device .7 6.2 Information on the packaging. 6.2.1 Unit container .8 6.2.2 Shipping container. 6.3 Information in the accompanying documents. ..8 6.4 Information in the accompanying documents in a prominent form Packaging ..9 Bibliography. ..10 iii ed without license from IHS